Jeil Medical Corporation
Jeil Medical Corporation has 0 FDA recalls, 1 inspection, 53 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jan 23, 2014 · OAI
- Latest 510(k)
- Apr 2, 2026
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 53 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 23, 2014 | Guro-Gu, Seoul, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3004049923 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004049923 | Guro-Gu, Seoul, Korea (The Republic Of) | 1 | Jan 23, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K252246 | Leforte MMF System | Apr 2, 2026 |
| K252826 | ARIX Femur Nail System | Dec 10, 2025 |
| K251431 | FIX-C PEEK ACIF SA System | Jun 27, 2025 |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jun 12, 2025 |
| K242751 | ARIX Pectus Bar System | May 30, 2025 |
| K242247 | ARIX Femur Nail System | Apr 22, 2025 |
| K243915 | FIX-C 3D Ti ACIF System | Feb 18, 2025 |
| K243004 | Xpine Spinal Fixation System | Nov 8, 2024 |
| K231251 | FlexWing Anterior Cervical Plate System | Jul 24, 2024 |
| K233912 | ARIX Cannulated Screw System | Mar 11, 2024 |
| K231887 | ARIX Ankle Distal Tibia System | Dec 14, 2023 |
| K231441 | ARIX Ankle System | Jul 17, 2023 |
| K230938 | ARIX Humerus System | May 3, 2023 |
| K221412 | ARIX Rib System | Nov 22, 2022 |
| K221920 | ARIX Small Fragment System | Aug 24, 2022 |
| K212266 | FIX-C PEEK Anterior Cervical Interbody System | Dec 21, 2021 |
| K202912 | ARIX Ankle Distal Tibia System | Oct 29, 2020 |
| K201656 | ARIX Elbow System | Sep 15, 2020 |
| K193616 | ARIX Ankle System | Mar 4, 2020 |
| K192417 | ARIX Cannulated Screw System | Nov 26, 2019 |
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